An Evaluation of the Information Presented in Published Articles: The Availability & Usefulness of data in Reproductive and Developmental Toxicity Risk Assessments
Public Deposited- Last Modified
- February 27, 2019
- Creator
-
Taulbee, Stephanie M.
- Affiliation: Gillings School of Global Public Health, Department of Environmental Sciences and Engineering
- Abstract
- The procedures for performing developmental and reproductive risk assessments have just been published by the Institute for Evaluating Health Risks. These procedures were published as guidelines and continue to be evaluated. Contained in this guidance are informational needs, some general to all toxicological risk assessment and some unique to developmental and reproductive risks. This technical report evaluates ninety-seven journal articles to assess whether the required information is contained in the articles and is in a useable form. The results show that there is a lack of detail in some articles for certain information that is necessary and useful to the risk assessor. Materials and Methods sections often lack adequate information about the parameters evaluated and the numbers of animals in the study or evaluate. Information on the analysis of the test chemical and dose formulation is more often than not incomplete or absent. One critical problem is that dose levels are sometimes presented as the concentration of the formulation and not as the delivered dose which is used by the risk assessor to compare risk levels and different study results in the results and discussion sections, there is incomplete discussion of all parameters evaluated and the relation of the results to human exposure and to assumptions made in interpreting the data in some articles. There appears to be incomplete presentation of the results for some developmental and reproductive parameters, particularly those that are not "interesting" or significant. In evaluating the results of this review, recommendations are made to authors, publishers and government regulators to promote more complete and consistent reporting of developmental and reproductive studies. The concept is to be aware of the needs of risk assessors and make a concerted effort to develop and publish data for this purpose.
- Date of publication
- May 1996
- DOI
- Resource type
- Rights statement
- In Copyright
- Advisor
- Crawford-Brown, Douglas J.
- Pierson, Terrence
- Shy, Carl M.
- Degree
- Master of Science in Public Health
- Academic concentration
- Environmental Management and Policy
- Degree granting institution
- University of North Carolina at Chapel Hill
- Graduation year
- 1996
- Language
- Deposit record
- 56f7e058-1c97-4774-9946-7afdcd8e0e36
Relations
- Parents:
This work has no parents.